Osteoradionecrosis Rate in Patients Undergoing Radiotherapy for Head and Neck Cancer Treatment.
Study Details
Study Description
Brief Summary
Objectives High-dose radiotherapy (RT) for head and neck cancer has significant adverse effects on maxillofacial tissues, among which osteoradionecrosis (ORN) is the most severe and potentially life-threatening. Although tooth extractions seem to be the main risk factor, few perspective studies evaluated protocols to minimize the ORN risk due to extractions. The aim of this study is to evaluate incidence and risk factors of ORN in a cohort of patients receiving tooth extractions before RT and evaluate an algorithm about extraction decision.
Methods One-hundred ten patients were consecutively recruited in this study: impacted third molars with radiographic sign of pericoronitis, teeth with periapical lesions, unrestorable teeth, periodontally compromised teeth (pocket probing depth >5 mm, clinical attachment loss
8 mm, grade 2 tooth mobility, II grade furcation involvement) were extracted under antibiotic prophylaxis. A 15-days interval between the last tooth extraction and the beginning of RT was recommended. Patients were visited at 15 days, 1, 3 and 6 months after the beginning of RT. Data of patients with a minimum of 6 months follow-up are presented in this report. ORN was defined as irradiated exposed necrotic bone, without healing for 3 months, in absence of cancer recurrence. The protocol was approved by the Ethic Committee of Catholic University - Fondazione Policlinico Gemelli (Prot. OHHN-1, ID-2132).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Osteoradionecrosis Incidence [60 months after the beginning of RT]
To evaluate the ORN incidence in a population irradiated for Head and Neck Cancer.
- Osteoradionecrosis rate following pre-radiotherapy tooth extraction [60 months after the beginning of RT]
Secondary Outcome Measures
- Extraction site: number of tooth extractions for each site (anterior and posterior maxilla or mandible and specific tooth number) and percentage of ORN for each site. [60 months after the beginning of RT]
Risk of ORN per extraction site
- Time interval between extraction and Radiotherapy: days between every tooth extraction and the beginning of RT. [60 months after the beginning of RT]
To understand the relationship between this time-lapse and the ORN incidence
- Surgical protocol 1: Flap elevation per each extracted tooth (YES/NO) and percentage of ORN per each type of procedure. [60 months after the beginning of RT]
Tooth extraction related risk factors
- Surgical protocol 2: Primary intention closure achievement per post-extractive site (YES/NO) and percentage of ORN per each type of procedure. [60 months after the beginning of RT]
Tooth extraction related risk factors
- Surgical protocol 3: Osteotomy per each extracted tooth (YES/NO) and percentage of ORN per each type of procedure. [60 months after the beginning of RT]
Tooth extraction related risk factors
- Reason for tooth extraction: number of tooth extraction for each cause under the protocol (caries, periodontal disease, endodontic lesions, pericoronitis, fracture) and percentage of ORN for each cause. [60 months after the beginning of RT]
Tooth extraction related risk factors
- Radiation dose to the post-extractive site (Gy of radiation received by every post-extractive site) [60 months after the beginning of RT]
Tooth extraction related risk factors
- Age of every patients at the beginning of RT [At baseline]
ORN risk factors
- Sex (male, female) of every patients at the beginning of RT [At baseline]
ORN risk factors
- Number of participants undergoing concurrent chemotherapy (neoadjuvant or concomitant) [During treatment]
ORN risk factors
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients willing to sign the informed consent form
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Patients with diagnosis of HNC, with specific prescription of local radiotherapy, both for curative and palliative purpose, with or without chemotherapic treatment.
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Patient with diagnosis of HNC, with specific prescription of local radiotherapy as an adjuvant to surgical resection, with or without chemotherapic treatment.
Exclusion Criteria:
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Patients participating to other clinical studies
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Patients who refuse to participate in the study
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Patients unable to attend the ambulatory visits scheduled by the protocol
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Catholic University of the Sacred Heart | Rome | Italy | 00168 |
Sponsors and Collaborators
- Catholic University of the Sacred Heart
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ORN-HN-1